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FDA 510(k), K200596, G21 Cement, VADER® Pedicle System
FDA 510(k), K200596, G21 Cement, VADER® Pedicle System
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510(K) Number: K200596
Device Name: G21 Cement, VADER® Pedicle System
Manufacturer: Icotec AG
Device Classification Name: Bone Cement, Posterior Screw Augmentation
Regulation Number: 888.3027
Classification Product Code: PML
Date Received: 03/06/2020
Decision Date: 10/13/2020
Regulation Medical Specialty: Orthopedic
Device Name: G21 Cement, VADER® Pedicle System
Manufacturer: Icotec AG
Device Classification Name: Bone Cement, Posterior Screw Augmentation
Regulation Number: 888.3027
Classification Product Code: PML
Date Received: 03/06/2020
Decision Date: 10/13/2020
Regulation Medical Specialty: Orthopedic
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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